The pericardium or epicardium are seen as the next frontier in heart therapy. It is possible to deliver drugs to the area and affect the heart without affecting other organs. Multiple groups have also ablated arrythmias from this region. However, a major barrier is that there is not a single tool designed specifically to access the epicardium. In fact currently the epicardium is typically accessed using a lumbar puncture needle which currently carries a high complication rate, thus limiting its use to expert centers only.
However, existing medical devices that can be used to obtain pericardial access, such as epidural needles and the like, are not designed to provide the clinician with an appropriate assessment of the pressures local to the needle tip during the process of advancing them into the pericardial space. For instance, those skilled in the art may recognize that the devices and methods taught in U.S. Pat. Nos. 7,101,362; 7,037,296; 6,554,809; 6,551,289; 6,273,877; 5,843,048; 5,725,504; 5,669,882; 5,484,423 and 4,349,023, all of which are incorporated by reference herein in their entirety, reflect standard usage of an elongated fluid sampling or delivery needle having a distal end and a proximal end, but which said devices are not optimized for use as pressure-sensing guideways for a sheath/catheter means within the pericardium. Commercially available needles, such as the Arrow International Corporation model AN-05505 Epidural Needle now in clinical use, are representative in design and function of this class of devices and reflect the limitations cited above with regard to pericardial access.
To overcome the limitations of using lumbar puncture needles and to take advantage of the above physiologic properties, various aspects of the embodiments of the present invention device and method of use have been provided.